Knowledge and Attitudes of Guam Residents towards Cancer Clinical Trial Participation.

(1) Background: Currently there are no cancer clinical trials in Guam, where CHamoru people suffer the highest rates of cancer mortality, and interest to do so is growing. This study investigated the knowledge and attitudes of Guam residents towards cancer clinical trial participation prior to implementation. (2) Methods: A telephone survey was developed, tested, and conducted among Guam resident adults, 18 years of age and older. Survey questions were summarized by descriptive statistics. Logistic regression models were used to investigate the associations between Guam residents' demographics and their clinical trial knowledge and attitudes. Adjusted odds ratios (aOR) and associated 95% confidence intervals (CI) were calculated. (3) Results: One hundred fifty-two people participated in the survey, most of whom were CHamoru (47.0%). Fifty-three percent had heard the term 'clinical trial'; 73.7% would take part in a trial if they had cancer; and 59.9% believed they would receive good quality treatment from a trial offered in Guam. CHamoru were more likely than Whites to associate out-of-pocket expenses with clinical trial participation (aOR = 5.34, 95% CI = 1.68-17.00). Physician ethnicity was important to 30% of non-Whites and significantly associated with those who spoke a language other than English (aOR = 3.40, 95% CI = 1.29-8.95). Most people (65.0%) did not believe clinical trials participants were 'guinea pigs'. (4) Conclusion: Though knowledge about cancer clinical trials is limited, attitudes were primarily positive towards participating in cancer clinical trials offered in Guam. Future delivery of cancer clinical trials will benefit from identifying potential barriers to recruitment and adopting an approach suited to Guam's population.

Preventive Care in Children and Adolescents.

This article describes the current state of migration of immigrant children into the United Sates and the various categories of immigrant children, including refugees, asylum seekers, unaccompanied minors, adoptees, and Special Immigrant Visa holders, hereafter called immigrant children. It focuses on guidelines for medical screening and management of newcomer immigrant children and adolescents and their ongoing preventive care. This article also addresses challenges unique to immigrant children and adolescents and the importance of culturally sensitive anticipatory guidance.

Diagnostic Biomarkers in Liver Injury by Drugs, Herbs, and Alcohol: Tricky Dilemma after EMA Correctly and Officially Retracted Letter of Support.

Liver injuries caused by the use of exogenous compounds such as drugs, herbs, and alcohol are commonly well diagnosed using laboratory tests, toxin analyses, or eventually reactive intermediates generated during metabolic degradation of the respective chemical in the liver and subject to covalent binding by target proteins. Conditions are somewhat different for idiosyncratic drug induced liver injury (DILI), for which metabolic intermediates as diagnostic aids are rarely available. Although the diagnosis of idiosyncratic DILI can well be established using the validated, liver specific, structured, and quantitative RUCAM (Roussel Uclaf Causality Assessment Method), there is an ongoing search for new diagnostic biomarkers that could assist in and also confirm RUCAM-based DILI diagnoses. With respect to idiosyncratic DILI and following previous regulatory letters of recommendations, selected biomarkers reached the clinical focus, including microRNA-122, microRNA-192, cytokeratin analogues, glutamate dehydrogenase, total HMGB-1 (High Mobility Group Box), and hyperacetylated HMGB-1 proteins. However, the new parameters total HMGB-1, and even more so the acetylated HMGB-1, came under critical scientific fire after misconduct at one of the collaborating partner centers, leading the EMA to recommend no longer the exploratory hyperacetylated HMGB1 isoform biomarkers in clinical studies. The overall promising nature of the recommended biomarkers was considered by EMA as highly dependent on the outstanding results of the now incriminated biomarker hyperacetylated HMGB-1. The EMA therefore correctly decided to officially retract its Letter of Support affecting all biomarkers listed above. New biomarkers are now under heavy scrutiny that will require re-evaluations prior to newly adapted recommendations. With Integrin beta 3 (ITGB3), however, a new diagnostic biomarker may emerge, possibly being drug specific but tested in only 16 patients; due to substantial remaining uncertainties, final recommendations would be premature. In conclusion, most of the currently recommended new biomarkers have lost regulatory support due to scientific misconduct, requiring now innovative approaches and re-evaluation before they can be assimilated into clinical practice.

Heart Toxicity Related to Herbs and Dietary Supplements: Online Table of Case Reports. Part 4 of 5.

BACKGROUND: The purpose of this review was to create an online research summary table of heart toxicity case reports related to dietary supplements (DS; includes herbs). METHODS: Documented PubMed case reports of DS appearing to contribute to heart-related problems were used to create a "Toxic Table" that summarized the research (1966 to April, 2016, and cross-referencing). Keywords included "herb," "dietary supplement," and cardiac terms. Case reports were excluded if they were herb combinations (some exceptions), Chinese herb mixtures, teas of mixed herb contents, mushrooms, poisonous plants, self-harm (e.g. suicide), excess dose (except vitamins/minerals), drugs or illegal drugs, drug-herbal interactions, and confounders of drugs or diseases. The spectrum of heart toxicities included hypertension, hypotension, hypokalemia, bradycardia, tachycardia, arrhythmia, ventricular fibrillation, heart attack, cardiac arrest, heart failure, and death. RESULTS: Heart related problems were associated with approximately seven herbs: Four traditional Chinese medicine herbs - Don quai (Angelica sinensis), Jin bu huan (Lycopodium serratum), Thundergod vine or lei gong teng (Tripterygium wilfordii Hook F), and Ting kung teng (Erycibe henryi prain); one an Ayruvedic herb - Aswagandha, (Withania somnifera); and two North American herbs - blue cohosh (Caulophyllum thalictroides), and Yohimbe (Pausinystalia johimbe). Aconitum and Ephedra species are no longer sold in the United States. The DS included, but are not limited to five DS - bitter orange, caffeine, certain energy drinks, nitric oxide products, and a calming product. Six additional DS are no longer sold. Licorice was the food related to heart problems. CONCLUSION: The online "Toxic Table" forewarns clinicians, consumers and the DS industry by listing DS with case reports related to heart toxicity. It may also contribute to Phase IV post marketing surveillance to diminish adverse events that Government officials use to regulate DS.

Cancer Related to Herbs and Dietary Supplements: Online Table of Case Reports. Part 5 of 5.

A current listing of potentially life-threatening, cancer-related dietary supplements (DSs; includes herbs) based on PubMed case reports was summarized in online tables that can now be updated continually to forewarn United States consumers, clinicians, and DS companies. Documented PubMed case reports were used to create a "Toxic Table" related to cancer (1966 to April 2016, and cross-referencing). Keywords included "herb" or "dietary supplement" combined with "cancer" as well as the specific herb "name" combined with "cancer" and sometimes "toxicity." Excluded were herb combinations (some exceptions), Chinese herb mixtures, teas of mixed herb contents, fungi (mycotoxins from molds and mushrooms), poisonous plants, self-harm, excessive doses (except vitamins/minerals), legal or illegal drugs, drug-herb interactions, and confounders of drugs or diseases related to cancer. Also included were a few foods related to cancer. Over the past 50+ years, PubMed case reports revealed an increased risk of cancer related to approximately one herb (guang fang ji), no dietary supplements (except those containing guang fang ji or aristolochic acid), and two foods (bracken fern, which is sometimes sold as an herbal supplement, and hot maté). This online "Toxic Table" can now be continually updated to assist researchers and clinicians in preventing serious adverse events from DSs related to cancer.

Anticancer activity of Morinda citrifolia (Noni) fruit: a review.

This review investigated the relationship of noni juice, or its extract (fruit, leaves or root), to anticancer and/or immunostimulant properties. A Medline search was conducted using the key search words 'Morinda citrifolia' and 'Morinda citrifolia and cancer' (1964 to October, 2011) along with cross-referencing. Botanical and chemical indexes were not included. A total of 304 and 29 (10%) articles, respectively, were found under these key terms. Of the 19 studies actually related to cancer, seven publications were in vitro cancer studies, nine were in vivo animal cancer studies, and three were in vivo human cancer studies. Among the in vitro studies, a 'concentrated component' in noni juice and not pure noni juice may (1) stimulate the immune system to 'possibly' assist the body fight the cancer, and (2) kill a small percentage (0-36%) of cancer cells depending on the type. The nine animal studies suggest that a concentrated component in noni juice may stimulate the immune system; but only slightly increases the number (about 1/3; 25-45%) of surviving mice. Other than two case studies, only two human clinical studies existed. The first consisted of testing freeze-dried noni fruit, which reduced pain perception, but did not reverse advanced cancer. The second was on smokers ingesting an unknown concentration of noni juice who experienced decreased aromatic DNA adducts, and decreased levels of plasma superoxide anion radicals and lipid hydroperoxide. Factors to consider in the future are clearly defining the substance being tested, and whether or not the juice is pasteurized. Some reports of hepatotoxicity exist, although there were confounding factors in most of the case reports. More importantly, noni juice is high in potassium and needs to be monitored by patients with kidney, liver or heart problems. In conclusion, a few in vitro and in vivo animal studies suggest a possible unidentified substance in unpasteurized noni fruit juice that may have a small degree of anticancer activity. The isolation of the active component warrants further research.

Gluten sensitivity: problems of an emerging condition separate from celiac disease.

Gluten sensitivity appears to be emerging as a separate condition from celiac disease, yet no clear definition or diagnosis exists. As a result, patients with gluten sensitivity experience delayed diagnosis and continuing symptoms if they consume gluten. This emerging medical problem may involve human genetics, plant genetic modifications, gluten as a food additive, environmental toxins, hormonal influences, intestinal infections and autoimmune diseases. The treatment is similar to that for celiac disease - a gluten-free diet. The use of a gluten-free diet or an elimination diet is encouraged in assisting people to determine whether or not they are gluten sensitive. It is time to not only recognize, but to treat and further research gluten sensitivity, as unconfirmed environmental factors continue to spread this problem further into the general population.

Autoimmune and gastrointestinal dysfunctions: does a subset of children with autism reveal a broader connection?

A large number of autoimmune disorders have a gastrointestinal (GI) dysfunction component that may interplay with genetic, hormonal, environmental and/or stress factors. This narrarive review investigates possible links between autism, immune system abnormalities and GI symptoms in a subgroup of children with autism. A literature search on Medline (1950 to September 2010) was conducted to identify relevant articles by using the keywords 'autism and gastrointestinal' (71 publications) and 'autism and immune' (237 publications), cross-referencing and general searching to evaluate the available literature on the immunological and GI aspects of autism. Sufficient evidence exists to support that a subgroup of children with autism may suffer from concomitant immune-related GI symptoms.

Existing dietary guidelines for Crohn's disease and ulcerative colitis.

Patients with inflammatory bowel disease (IBD) often question their doctors about diet. The objectives of this article are to provide clinicians with existing dietary advice by presenting the dietary information proposed by medical societies in the form of clinical practice guidelines as it relates to IBD; listing dietary guidelines from patient-centered IBD-related organizations; and creating a new 'global practice guideline' that attempts to consolidate the existing information regarding diet and IBD. The dietary suggestions derived from sources found in this article include nutritional deficiency screening, avoiding foods that worsen symptoms, eating smaller meals at more frequent intervals, drinking adequate fluids, avoiding caffeine and alcohol, taking vitamin/mineral supplementation, eliminating dairy if lactose intolerant, limiting excess fat, reducing carbohydrates and reducing high-fiber foods during flares. Mixed advice exists regarding probiotics. Enteral nutrition is recommended for Crohn's disease patients in Japan, which differs from practices in the USA.

Does evidence exist to include dietary therapy in the treatment of Crohn's disease?

Prescription drugs and surgery are two common medical therapies for Crohn's disease (CD), an inflammatory bowel disease that affects the GI tract. Unfortunately, certain drugs can cause serious side effects, and surgeries must often be repeated. No diet has been established to alleviate the pain and suffering of CD patients. This is curious given the fact that a higher prevalence of food sensitivities exist in this population of patients, and enteral nutrition is not only the first-line of therapy in Japan, but a known research method used to place the majority of CD patients into remission. Although not all patients respond equally to diet, many simply remove symptom-provoking foods, such as dairy, wheat, corn and certain fruits and vegetables. We suggest assisting these patients in their self-assessment of irritating and symptom-provoking foods by educating them in the use of a food-symptom diary followed by a customized elimination diet trialed for 2-4 weeks to determine if there is any benefit to the individual patient.

Position of the American Dietetic Association: functional foods.

All foods are functional at some physiological level, but it is the position of the American Dietetic Association (ADA) that functional foods that include whole foods and fortified, enriched, or enhanced foods have a potentially beneficial effect on health when consumed as part of a varied diet on a regular basis, at effective levels. ADA supports research to further define the health benefits and risks of individual functional foods and their physiologically active components. Health claims on food products, including functional foods, should be based on the significant scientific agreement standard of evidence and ADA supports label claims based on such strong scientific substantiation. Food and nutrition professionals will continue to work with the food industry, allied health professionals, the government, the scientific community, and the media to ensure that the public has accurate information regarding functional foods and thus should continue to educate themselves on this emerging area of food and nutrition science. Knowledge of the role of physiologically active food components, from plant, animal, and microbial food sources, has changed the role of diet in health. Functional foods have evolved as food and nutrition science has advanced beyond the treatment of deficiency syndromes to reduction of disease risk and health promotion. This position paper reviews the definition of functional foods, their regulation, and the scientific evidence supporting this evolving area of food and nutrition. Foods can no longer be evaluated only in terms of macronutrient and micronutrient content alone. Analyzing the content of other physiologically active components and evaluating their role in health promotion will be necessary. The availability of health-promoting functional foods in the US diet has the potential to help ensure a healthier population. However, each functional food should be evaluated on the basis of scientific evidence to ensure appropriate integration into a varied diet.

Ginger's (Zingiber officinale Roscoe) inhibition of rat colonic adenocarcinoma cells proliferation and angiogenesis in vitro.

Ginger's (Zingiber officinale Roscoe) natural bioactives, specifically ginger extract and 6-gingerol, were measured for their in vitro inhibition of two key aspects of colon cancer biology--cancer cell proliferation and angiogenic potential of endothelial cell tubule formation. Ginger extract was obtained via column distillation, while the 6-gingerol was purchased from Calbiochem. Antiproliferation activity was assessed through tritiated thymidine ([(3)H]Tdr) incorporation studies of YYT colon cancer cells; the anti-angiogenic ability of gingerol was assessed by a Matrigel assays using MS1 endothelial cells. These selected ginger bioactives had: 1) a direct effect on YYT rat cancer cell proliferation (6-1.5% ginger extract; 100-4 microM 6-gingerol); 2) an indirect effect on MS1 endothelial cell function either at the level of endothelial cell proliferation or through inhibition of MS1 endothelial cell tube formation (100-0.8 microM). Compound 6-gingerol was most effective at lower doses in inhibiting endothelial cell tube formation. These in vitro studies show that 6-gingerol has two types of antitumor effects: 1) direct colon cancer cell growth suppression, and 2) inhibition of the blood supply of the tumor via angiogenesis. Further research is warranted to test 6-gingerol in animal studies as a potential anticancer plant bioactive in the complementary treatment of cancer.

Traditional kava beverage consumption and liver function tests in a predominantly Tongan population in Hawaii.

PURPOSE: To determine the effects of traditionally prepared kava beverages on the liver function tests of regular kava beverage consumers in a population of Tongan and non-Tongan residents of Hawaii (Oahu). METHODS: The liver function tests of 31 healthy adult kava drinkers were compared against a control group of 31 healthy adult non-kava drinkers. Subjects were recruited from the general population, a kava bar, and Tongan kava drinking circles. The liver function profile included AST, ALT, ALP, GGT, and bilirubin (total and direct). Other tests included total protein, albumin, and screens for viral hepatitis and hemochromatosis when indicated. RESULTS: Chronic kava beverage consumption was associated with elevation of GGT in 65% of the kava drinkers versus 26% in the controls (P = .005). ALP was elevated in 23% of kava drinkers versus 3% in the controls (P = .053). CONCLUSION: Heavy kava beverage consumption was associated with significantly elevated GGT levels.

The anti-cancer effects of poi (Colocasia esculenta) on colonic adenocarcinoma cells In vitro.

Hawaiians tend to have lower incidence rates of colorectal cancer and it was hypothesized that this may be due to ethnic differences in diet, specifically, their consumption of poi, a starchy paste made from the taro (Colocasia esulenta L.) plant corm. Soluble extracts of poi were incubated at 100 mg/mL in vitro for antiproliferative activity against the rat YYT colon cancer cell line. (3)H-thymidine incorporation studies were conducted to demonstrate that the poi inhibited the proliferation of these cancer cells in a dose-dependent manner. The greatest suppression of YYT colon cancer growth occurred when 25% concentration was used. When poi was incubated with the YYT cells after 2 days, the YYT cells underwent apoptotic changes as evidenced by a positive terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (TUNEL) stain. Poi enhanced the proliferation of normal mouse splenocyte control cells, suggesting that poi is not simply toxic to all cells but even has a positive immunostimulatory role. By flow cytometry, T cells (CD4+ and CD8+) were predominantly activated by the poi. Although numerous factors can contribute to the risk of colon cancer, perhaps poi consumption may contribute to the lower colon cancer rates among Hawaiians by two distinct mechanisms. First, by inducing apoptosis within colon cancer cells; second, by non-specifically activating lymphocytes, which in turn can lyse cancerous cells. Our results suggest for the first time that poi may have novel tumor specific anti-cancer activities and future research is suggested with animal studies and human clinical trials.

Effectiveness of kukui nut oil as a topical treatment for psoriasis.

BACKGROUND: No cure for psoriasis exists for the 1-3% of the American population who suffer from it; however, anecdotal reports from patients with psoriasis visiting Hawaii who purchased kukui nut oil, claim it helped reduce the severity of their lesions. OBJECTIVE: This pilot study was a double-blind, placebo-controlled clinical trial to determine the effectiveness of kukui nut oil as a topical treatment for psoriasis. METHODS: Thirty adult subjects (18-78 year) were recruited from the community for a 12-week randomized, double-blind, placebo-controlled pilot study. Subjects were previously diagnosed with mild, stable plaque psoriasis (less than 15% of total body surface area [TBSA]) and agreed to abstain from other treatments during the course of the study. Following a 4-week washout period the subjects were randomized into a treatment group (15 subjects applying kukui nut oil) or a control group (15 applying the mineral oil placebo). Patients were seen every 2 weeks (seven visits at 0, 2, 4, 6, 8, 10, and 12 weeks) by a dermatological nurse practitioner under the general supervision of a board certified dermatologist. Measurable outcomes included evaluation of one targeted lesion and of the overall severity of their psoriasis using clinical evaluation, Psoriasis Area and Sensitivity Index (PASI), Global Severity of Psoriasis Scale, and photographs. Each patient also evaluated their own lesions daily using the Global Severity of Psoriasis Scale, and noted any side-effects or other treatments used. RESULTS: Although both groups improved, we found no significant difference between the treatment (kukui nut oil) and the placebo (mineral oil) among the 24 out of 30 subjects (80%) who completed the study. No side-effects or adverse events were reported. CONCLUSION: Kukui nut oil did not significantly reduce symptoms of psoriasis; however, this was a small pilot study, and the use of this oil cannot be dismissed without using a larger study population of patients with psoriasis.

A non-dairy probiotic's (poi) influence on changing the gastrointestinal tract's microflora environment.

JUSTIFICATION: Yogurt has been historically used to restore gut microflora adversely affected by antibiotic treatment. Certain fermented dairy products are probiotics; "live microorganisms which when administered in adequate amounts confer a health benefit to the host." Microorganisms in foods may benefit certain health conditions such as diarrhea, gastroenteritis, irritable bowel syndrome, inflammatory bowel disease, and cancer. A potential new probiotic from a Polynesian traditional food is poi; a starchy paste made from the corm of taro plants. OBJECTIVE: The purpose of this study was to determine if consumption of poi, a potential non-dairy probiotic, altered the microflora in the gastrointestinal tract of healthy adults. METHODS: A cross-over clinical study included 18 subjects (19-64 years of age) divided into a poi group (n = 10) and control group (n = 8). The study duration of 14 weeks consisted of a 2-week washout, 4-week treatment or control, a subsequent 2-week washout, cross-over of 4-week treatment or control, and a final 2-week washout. Subjects thus served as their own controls. While receiving the poi treatment, participants consumed fresh poi (1-2 days old) three times a day (130 g/meal or approximately 1/2 cup/meal); the control group did not. Both groups filled out 3-day dietary records to ensure compliance. Measurable outcomes included pre- and post-treatment microbiological fecal culture analyses. RESULTS: We found no significant differences in total bacterial counts following a poi diet versus following a control diet, nor were significant differences found in counts of specific bacterial species. Lactococcus tends to be higher in poi when it is analyzed for specific bacteria, but the poi consumption in our study did not alter the mean concentration of individual bacterial species (log10 CFU/g wet feces) for Escherichia coli, Enterobacter, Klebsiella, Lactobacillus, Lactococcus, and Bifidobacterium. No significant differences in stool frequency or consistency were observed between the treatment and control group periods. CONCLUSION: Poi consumption did not significantly alter total or individual bacterial counts in the human gastrointestinal tract. Further research might determine if "sour poi" (3-4 days old) has a greater affect than "fresh poi" (1-2 days old) as a potential probiotic, and a larger trial with longer diet durations may detect more subtle effects of poi consumption on bacterial counts.